Behavioral Therapy Development for Methamphetamine Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252434
Recruitment Status : Terminated (Slow enrollment)
First Posted : November 11, 2005
Last Update Posted : January 27, 2016
Information provided by:
University of California, Los Angeles

Brief Summary:
The purpose of this study is to evaluate whether a specially developed group counseling approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV medications than a standard drug treatment program. Another purpose is to determine whether having a drug abuse treatment program in an HIV medical clinic makes it easier to attend treatment than going to a separate location for drug abuse treatment.

Condition or disease Intervention/treatment Phase
Depression Drug Abuse Sexually Transmitted Diseases Behavioral: Cognitive Behavioral Therapy Development for Methamphetamine Abuse Phase 1

Detailed Description:
The study features activities that include development and refinement of a culturally-specific cognitive behavioral therapy that integrates aspects of drug abuse treatment with HIV medication adherence interventions and cultural elements of being a gay or bisexual man receiving medical care for HIV/AIDS. To estimate the size of the signal of this intervention, the study proposes a two parallel group design in which 50 treatment-seeking HIV-seropositive gay and bisexual men who meet criteria for methamphetamine abuse and who receive HIV medical care at the UCLA Center for Clinical AIDS Research and Education (CARE) clinic are randomized to the study condition or a treatment-as-usual (TAU) condition. Participants assigned to the experimental condition receive 12 weeks of twice-weekly GCBT, with a 6-months post-randomization follow-up visit. Participants assigned to the TAU condition are referred to the UCLA Addiction Medicine Clinic (AMC), where they receive the clinic's standard of care treatment for methamphetamine dependence for 12 weeks, and return for a 6-month follow-up visit. Analyses are conducted on all participants who meet inclusion/exclusion criteria, express desire for treatment, and receive at least one "dose" of the cognitive-behavioral treatment or make one visit to the AMC. Participants in both conditions agree to weekly and monthly data collection visits, including the provision of urine samples. Primary outcome variables are methamphetamine use, sexual risk behaviors, and HIV medication compliance. The proposed design maintains the focus on intervention development and feasibility, while recognizing that the second phase of this development will be informed by having accurate estimates of effect sizes for the intervention and adequate resources to conduct the full-scale trial.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Therapy Development for Methamphetamine Abuse
Study Start Date : August 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Primary Outcome Measures :
  1. methamphetamine use [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. sexual risk behaviors [ Time Frame: monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male

Inclusion Criteria:

  1. HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the University of California, Los Angeles (UCLA) Center for Clinical AIDS Research and Education (CARE) clinic, aged 18-65
  2. Willing to give informed consent and comply with study procedures
  3. Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications
  4. Diagnosed with current methamphetamine abuse as determined by Mini-International Neuropsychiatric Interview (MINI)
  5. Interested in seeking treatment for methamphetamine abuse and in participating in this research project.

Exclusion Criteria:

  1. Unwilling to give, or withdrawal of, informed consent
  2. Inability to understand nature of study
  3. A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria for current bipolar disorder or a psychotic disorder)
  4. Current suicidal ideation or suicide attempt within the past 3 months
  5. Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
  6. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252434

United States, California
UCLA Center for Clinical AIDS Research and Education (CARE) Clinic
Los Angeles, California, United States, 90035
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: James A. Peck, PsyD. UCLA Integrated Substance Abuse Programs
Principal Investigator: James A Peck, Psy.D. UCLA Integrated Substance Abuse Programs Identifier: NCT00252434     History of Changes
Other Study ID Numbers: 1R21DA018075 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by University of California, Los Angeles:
high-risk sexual behavior
methamphetamine use
drug craving
addiction behaviors

Additional relevant MeSH terms:
Substance-Related Disorders
Sexually Transmitted Diseases
Chemically-Induced Disorders
Mental Disorders
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors